Metabolic SyndromeNCT02077530
Metabolic Syndrome Cohort in Korea
An observational study of Metabolic Syndrome, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
Patients with metabolic syndrome living in Seoul area are included in this prospective registry for more than 10 years. All enrolled patients undergo thorough medical history survey. Read more about this study
- Who is it for?
- Ages 30 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Nov 2023
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with metabolic syndrome living in Seoul area
Who may be able to join
- Central obesity: Men ≥ 90 cm Women ≥ 85 cm
- Plasma triglycerides ≥ 150 mg/dL
- HDL cholesterol Men < 40 mg/dL, Women < 50 mg/dL
- Blood pressure ≥130/85 mm Hg (or treatment for hypertension)
- Fasting plasma glucose ≥ 100 mg/dL
- Age between 30 to 64
- Consent to our registry protocol
Who cannot join
- Patients who could not undergo coronary CT, 2D echocardiogram, treadmill test, and pulse wave velocity.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea University Anam Hospital Metabolic Syndrome Research Center
Seoul, 136-705
About this study
Patients with metabolic syndrome living in Seoul area are included in this prospective registry for more than 10 years. All enrolled patients undergo thorough medical history survey. Enrolled patients will have coronary CT, 2D echocardiogram, treadmill test, pulse wave velocity, augmentation index, carotid intima-media thickness, and abdominal fat mass evaluation. Moreover, lipid profiles and inflammatory markers such as hsCRP, IL-6, TNF-alpha, VCAM-1, ICAM-1, adiponectin, MMP-9 will be measured. All participants will repeat the test and survey every year in Korea University Hospital.
- Conditions
- Metabolic Syndrome
- Keywords
- Patients with metabolic syndrome age between 30 to 64: Central obesity (Men ≥ 90 cm Women ≥ 85 cm), Plasma triglycerides ≥ 150 mg/dL, HDL cholesterol Men < 40 mg/dL, Women < 50 mg/dL, Blood pressure ≥130/85 mm Hg (or treatment for hypertension),, Fasting plasma glucose ≥ 100 mg/dL
- Medical subject headings
- Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular events
Cardiovascular events such as fatal and non-fatal myocardial infarction, heart failure, need for coronary and peripheral revascularization, stroke, all-cause death, and cardiac death.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soon Jun Hong, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077530
- Sponsor's protocol ID
- MS in KUMC
- Status last verified
- Nov 2020
- First submitted
- 2 Mar 2014
- Last updated
- 10 Nov 2020
- Results posted
- No
Publications
Cho DH, Kim MN, Joo HJ, Shim WJ, Lim DS, Park SM. Visceral obesity, but not central obesity, is associated with cardiac remodeling in subjects with suspected metabolic syndrome. Nutr Metab Cardiovasc Dis. 2019 Apr;29(4):360-366. doi: 10.1016/j.numecd.2019.01.007. Epub 2019 Jan 29.
PubMed 30782509Lee D, Joo HJ, Jung HW, Lim DS. Investigating potential mediator between statin and coronary artery calcification. PLoS One. 2018 Sep 18;13(9):e0203702. doi: 10.1371/journal.pone.0203702. eCollection 2018.
PubMed 30226851Cho DH, Joo HJ, Kim MN, Lim DS, Shim WJ, Park SM. Association between epicardial adipose tissue, high-sensitivity C-reactive protein and myocardial dysfunction in middle-aged men with suspected metabolic syndrome. Cardiovasc Diabetol. 2018 Jun 30;17(1):95. doi: 10.1186/s12933-018-0735-7.
PubMed 29960588Joo HJ, Cho SA, Cho JY, Lee S, Park JH, Yu CW, Hong SJ, Lim DS. Different Relationship Between Physical Activity, Arterial Stiffness, and Metabolic Status in Obese Subjects. J Phys Act Health. 2017 Sep;14(9):716-725. doi: 10.1123/jpah.2016-0595. Epub 2017 May 17.
PubMed 28513244
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Syndrome Cohort in Korea
- ClinicalTrials.gov ID
- NCT02077530
- Acronym / sponsor ID
- MS in KUMC
- Conditions
- Metabolic Syndrome
- Keywords
- Patients with metabolic syndrome age between 30 to 64: Central obesity (Men ≥ 90 cm Women ≥ 85 cm), Plasma triglycerides ≥ 150 mg/dL, HDL cholesterol Men < 40 mg/dL, Women < 50 mg/dL, Blood pressure ≥130/85 mm Hg (or treatment for hypertension),, Fasting plasma glucose ≥ 100 mg/dL
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with metabolic syndrome living in Seoul area are included in this prospective registry for more than 10 years. All enrolled patients undergo thorough medical history survey. Enrolled patients will have coronary CT, 2D echocardiogram, treadmill test, pulse wave velocity, augmentation index, carotid intima-media thickness, and abdominal fat mass evaluation. Moreover, lipid profiles and inflammatory markers such as hsCRP, IL-6, TNF-alpha, VCAM-1, ICAM-1, adiponectin, MMP-9 will be measured. All participants will repeat the test and survey every year in Korea University Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 30 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with metabolic syndrome living in Seoul area
Key inclusion criteria (7 listed)
- Central obesity: Men ≥ 90 cm Women ≥ 85 cm
- Plasma triglycerides ≥ 150 mg/dL
- HDL cholesterol Men < 40 mg/dL, Women < 50 mg/dL
- Blood pressure ≥130/85 mm Hg (or treatment for hypertension)
- Fasting plasma glucose ≥ 100 mg/dL
Key exclusion criteria (1 listed)
- Patients who could not undergo coronary CT, 2D echocardiogram, treadmill test, and pulse wave velocity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular events
Time frame: 10 years
Cardiovascular events such as fatal and non-fatal myocardial infarction, heart failure, need for coronary and peripheral revascularization, stroke, all-cause death, and cardiac death.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Derived from this study: PubMed 30782509Cho DH, Kim MN, Joo HJ, Shim WJ, Lim DS, Park SM. Visceral obesity, but not central obesity, is associated with cardiac remodeling in subjects with suspected metabolic syndrome. Nutr Metab Cardiovasc Dis. 2019 Apr;29(4):360-366. doi: 10.1016/j.numecd.2019.01.007. Epub 2019 Jan 29.
- Derived from this study: PubMed 30226851Lee D, Joo HJ, Jung HW, Lim DS. Investigating potential mediator between statin and coronary artery calcification. PLoS One. 2018 Sep 18;13(9):e0203702. doi: 10.1371/journal.pone.0203702. eCollection 2018.
- Derived from this study: PubMed 29960588Cho DH, Joo HJ, Kim MN, Lim DS, Shim WJ, Park SM. Association between epicardial adipose tissue, high-sensitivity C-reactive protein and myocardial dysfunction in middle-aged men with suspected metabolic syndrome. Cardiovasc Diabetol. 2018 Jun 30;17(1):95. doi: 10.1186/s12933-018-0735-7.
- Derived from this study: PubMed 28513244Joo HJ, Cho SA, Cho JY, Lee S, Park JH, Yu CW, Hong SJ, Lim DS. Different Relationship Between Physical Activity, Arterial Stiffness, and Metabolic Status in Obese Subjects. J Phys Act Health. 2017 Sep;14(9):716-725. doi: 10.1123/jpah.2016-0595. Epub 2017 May 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by Korea University Anam Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular events (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02077530, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.